Analysis of a Randomized, Placebo-Controlled Trial Evaluating an Oral Nutraceutical Supplement and Topical Peptide Serum for Females with Self-Perceived Hair Thinning

Introduction: Androgenetic Alopecia (AGA) affects up to 50% of women, and women with AGA report greater social insecurity and lower self-esteem than men with AGA and than women without hair loss. Because enrollment in this trial was based on self-perceived thinning, participants' perception of their own hair is a primary outcome of interest alongside objective hair density. The intervention pairs an oral nutrient blend gummy (NAD⁺, pumpkinseed extract, taurine, saw palmetto, micronutrients) with a topical peptide serum (GHK-Cu, Zinc Thymulin, BPC-157). The purpose of this interim analysis was to characterize the patient experience of treatment using validated patient-reported outcomes. Methods: This is a multicenter, randomized, double-blind, placebo-controlled trial (Part A, Day 0–84) with an open-label extension (Part B, Day 84–252). Women aged 28–65 years with Ludwig I–II AGA were randomized 1:1 to the active treatment (two gummies daily, 1 mL serum nightly) or matched placebo; placebo subjects crossed over to the active product at Day 84. Two instruments were administered at baseline, Day 84, Day 168, and Day 252: the Women's Androgenetic Alopecia Subjective Questionnaire (WAASQ), a 13-item measure of hair-related self-consciousness, confidence, embarrassment, concern, and concealment time (each 0–5; total 0–65, higher = more distress; adapted from the Women's Androgenetic Alopecia Quality of Life Questionnaire (WAA-QoL), and the Patient Global Impression of Severity (PGIS), a single item scored 0 (none) to 4 (very severe) rated against a same-day scalp photograph. This interim analysis reflects a single site: 54 enrolled, 43 with a baseline and at least one follow-up questionnaire. Results are pooled by months on active product; for placebo-randomized subjects, the Day 84 visit (start of active treatment) served as the treatment baseline, so no placebo-period data are included. Within-subject change from treatment start was assessed with Wilcoxon signed-rank tests and unadjusted p-values. Results: Hair-related distress fell steadily with time on product: a 7-point (24%) WAASQ reduction after 3 months, 10.5 points (36%) after 6 months, and 13.5 points (43%) after 9 months (all p ≤ .011). On the PGIS, the share of subjects rating their hair loss as none or mild rose from 21% at treatment start to 50% at 3 months, and approximately three in four at 6 and 9 months (74% and 71%, respectively). Global photographic hair mapping at treatment start and follow-up qualitatively supported these findings. Conclusions: Women using the active gummy plus serum combination felt progressively better about their hair over time, with roughly three in four rating their hair loss as none or mild after six to nine months. As a single-arm, within-subject, unblinded interim analysis without a concurrent untreated comparator, these results describe the patient experience of treatment rather than a demonstrated product effect; end-of-study analysis will pair them with objective hair-density data.